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| Sponsored by: |
National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00001008 |
Purpose
To determine if methadone treatment will affect the blood levels of zidovudine (AZT) in patients with AIDS or AIDS-related complex (ARC) who are receiving oral AZT and methadone therapy. In addition, the blood levels of methadone both before and during AZT treatment will be studied, and patients receiving daily oral methadone treatment will be evaluated for signs of narcotic withdrawal during treatment with AZT.
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
| Condition | Intervention |
|---|---|
|
HIV Infections |
Drug: Methadone hydrochloride Drug: Zidovudine |
| Study Type: | Interventional |
| Study Design: | Treatment, Parallel Assignment, Pharmacokinetics Study |
| Official Title: | Pharmacokinetic Study of the Interaction of Azidothymidine and Methadone in Patients With AIDS and ARC |
| Estimated Enrollment: | 18 |
The number of deaths due to AIDS in high-risk populations continues to increase. Nationwide approximately 25 percent of AIDS patients are intravenous (IV) drug abusers, and it is very likely that an increasingly larger number of AIDS patients receiving AZT therapy will have had a history of IV drug abuse. The major chemical treatment for IV drug abuse is daily methadone maintenance therapy, and IV drug abusers who are HIV positive represent a large number of patients who will undergo long-term treatment with both methadone and AZT. Therefore, the study of potential drug interactions is essential.
The 18 patients are patients with AIDS or ARC. Nine are control patients who are not receiving methadone and are not IV drug abusers. Nine are former IV drug abusers who have been maintained on methadone for at least 6 months and who have been receiving a constant daily dose of methadone for at least 1 month. Plasma and urine levels of methadone are determined over a 4 hour period. The dose of AZT: For the pharmacokinetic study of AZT, plasma and urine samples are taken after oral dose of AZT and an intravenous dose of AZT in the control and methadone groups.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
Prior Medication:
Allowed:
The study will include 18 patients with AIDS or HIV-related symptomatic illness as defined by the CDC classification group IVa and c2. Of these, 9 methadone recipients will have been maintained on methadone for at least 1 month and will have received a constant daily dose of 30-90 mg of methadone for at least 10 days.
Nine patients will be former intravenous drug abusers.
Exclusion Criteria
Co-existing Condition:
Patients with the following symptoms or conditions are excluded:
Concurrent Medication:
Excluded:
Patients with the following symptoms or conditions are excluded:
Prior Medication:
Excluded within 72 hours of study entry:
Active drug or alcohol abuse.
Contacts and Locations More Information
| Study ID Numbers: | ACTG 055 |
| Study First Received: | November 2, 1999 |
| Last Updated: | July 11, 2008 |
| ClinicalTrials.gov Identifier: | NCT00001008 History of Changes |
| Health Authority: | United States: Federal Government |
|
Substance Withdrawal Syndrome Methadone Opioid-Related Disorders Drug Evaluation Drug Interactions |
Drug Therapy, Combination Administration, Oral Acquired Immunodeficiency Syndrome AIDS-Related Complex Zidovudine |
|
Antimetabolites Sexually Transmitted Diseases, Viral Substance Withdrawal Syndrome Zidovudine Opioid-Related Disorders Reverse Transcriptase Inhibitors Naphazoline Anti-Retroviral Agents Phenylpropanolamine Analgesics Retroviridae Infections Analgesics, Opioid Anti-HIV Agents |
Acquired Immunodeficiency Syndrome Central Nervous System Depressants AIDS-Related Complex Narcotics Antiviral Agents Immunologic Deficiency Syndromes Virus Diseases Methadone HIV Infections Guaifenesin Sexually Transmitted Diseases Peripheral Nervous System Agents |
|
Antimetabolites Anti-Infective Agents Respiratory System Agents Sexually Transmitted Diseases, Viral Slow Virus Diseases Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Zidovudine Infection Reverse Transcriptase Inhibitors Anti-Retroviral Agents Sensory System Agents Therapeutic Uses Analgesics Retroviridae Infections |
Nucleic Acid Synthesis Inhibitors Analgesics, Opioid RNA Virus Infections Anti-HIV Agents Immune System Diseases Acquired Immunodeficiency Syndrome Central Nervous System Depressants Enzyme Inhibitors AIDS-Related Complex Narcotics Antiviral Agents Immunologic Deficiency Syndromes Pharmacologic Actions Virus Diseases Methadone |
